FDA 510(k) Application Details - K200509

Device Classification Name System, Test, Vitamin D

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510(K) Number K200509
Device Name System, Test, Vitamin D
Applicant Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue
Tarrytown, NY 102591 US
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Contact Paul DaSilva
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Regulation Number 862.1825

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Classification Product Code MRG
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Date Received 03/02/2020
Decision Date 05/29/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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